MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC YES; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735428
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system used during a catheter placement procedure.It was reported that the stylet was tracking while in navigation and then stopped tracking while still in navigation.Site was using a non-invasive patient tracker and a flat emitter.Issue was resolved when a new stylet was opened.The site reported no metal in the field, and attempted to plug the stylet into multiple different ports on the break out box with no effect.Technical services (ts) had site confirm that the stylet was included in the instruments tab for the procedure.Site reported that the stylet was green in the instruments tab and red in the navigation task.Ts had the site bring in a "pencil" (registration probe) to use in the same ports on the break out box.Site confirmed that the probe was tracking when plugged into the same ports that the stylet had been plugged into.Ts advised site to open a new stylet.This resulted in a less than 30 min delay to the case.There was no impact on patient outcome.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.F1908: delay of less than one hour f26: no patient impact h3, h6: the returned stylet was analyzed.It would not track when connected to a known good system, displaying only red status.A check of the em interface showed that both coils were normal.Codes b01, c13, c07, and d02 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: YES
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21424047
• Report Number: 1723170-2025-00848
• Device Sequence Number: 20753235
• Product Code: HAW
• UDI-Device Identifier: 00763000588489
• UDI-Public: 00763000588489
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: 9735428
• Device Catalogue Number: 9735428
• Device Lot Number: 220126A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG